Gastric band

ABSTRACT

A gastric band includes a balloon shaped and dimensioned to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body and a supply tube is secured to the balloon for fluid communication with an internal cavity of the balloon.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of U.S. patent applicationSer. No. 11/182,072, entitled “LATCHING DEVICE FOR GASTRIC BAND”, filedJul. 15, 2005, which is currently pending, and claims the benefit ofU.S. Provisional Application Ser. No. 60/699,369, entitled “GASTRICBAND”, filed Jul. 15, 2005.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a gastric band and related accessories.

2. Description of the Prior Art

Morbid obesity is a serious medical condition. In fact, morbid obesityhas become highly pervasive in the United States, as well as othercountries, and the trend appears to be heading in a negative direction.Complications associated with morbid obesity include hypertension,diabetes, coronary artery disease, stroke, congestive heart failure,multiple orthopedic problems and pulmonary insufficiency with markedlydecreased life expectancy. With this in mind, and as those skilled inthe art will certainly appreciate, the monetary and physical costsassociated with morbid obesity are substantial. In fact, it is estimatedthe costs relating to obesity are in excess of one hundred billiondollars in the United States alone.

A variety of surgical procedures have been developed to treat obesity.The most common currently performed procedure is Roux-en-Y gastricbypass (RYGB). This procedure is highly complex and is commonly utilizedto treat people exhibiting morbid obesity. Other forms of bariatricsurgery include Fobi pouch, bilio-pancreatic diversion, andgastroplastic or “stomach stapling”. In addition, implantable devicesare known which limit the passage of food through the stomach and affectsatiety.

In view of the highly invasive nature of many of these procedures,efforts have been made to develop less traumatic and less invasiveprocedures. Gastric-banding is one of these methods. Gastric-banding isa type of gastric reduction surgery attempting to limit food intake byreducing the size of the stomach. In contrast to RYGB and other stomachreduction procedures, gastric-banding does not require the alteration ofthe anatomy of the digestive tract in the duodenum or jejunum.

Since the early 1980's, gastric bands have provided an effectivealternative to gastric bypass and other irreversible surgical weightloss treatments for the morbidly obese. Several alternate procedures areperformed under the heading of gastric-banding. Some banding techniquesemploy a gastric ring, others use a band, some use stomach staples andstill other procedures use a combination of rings, bands and staples.Among the procedures most commonly performed are vertical bandedgastroplasty (VBG), silastic ring gastroplasty (SRG) and adjustablesilastic gastric banding (AGB).

In general, the gastric band is wrapped around an upper portion of thepatient's stomach, forming a stoma that is less than the normal interiordiameter of the stomach. This restricts food passing from an upperportion to a lower digestive portion of the stomach. When the stoma isof an appropriate size, food held in the upper portion of the stomachprovides a feeling of fullness that discourages over eating.

More particularly, and in practice, the gastric band is inserted behindthe stomach and the ends of the gastric band are coupled to latch thedevice about the stomach. However, it is often difficult to maneuver theends of the gastric band for proper latching. As such, mechanisms forenhancing the application of gastric bands about a stomach are needed.The present invention provides such a mechanism in the form of anextension device for utilization in conjunction with currently availablegastric bands, which is removable after the gastric band is properlyinstalled. The present invention also provides an improved gastric bandconstruction facilitating ease of application about a stomach andenhanced functionality once applied.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide agastric band including a balloon shaped and dimensioned to circumscribethe stomach at a predetermined location. The balloon includes alongitudinally extending body and a supply tube secured to the balloonfor fluid communication with an internal cavity of the balloon.

Other objects and advantages of the present invention will becomeapparent from the following detailed description when viewed inconjunction with the accompanying drawings, which set forth certainembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the suture tab extender secured to agastric band.

FIG. 2 is a perspective view of the removable suture tab extender.

FIG. 3 is a perspective view of the gastric band secured about thestomach.

FIGS. 4, 5 and 5 a are various perspective views of a gastric band inaccordance with the present invention.

FIGS. 6, 7 and 8 show the various steps in the attachment of the gastricband using the present suture tab extender.

FIG. 9 is a perspective view of a suture tab extender in accordance witha further embodiment.

FIG. 10 is a perspective view of a suture tab extender in accordancewith an alternate embodiment.

FIGS. 11, 12, 13 and 14 respectively show a perspective view of aballoon, a perspective view of a belt, a cross sectional view of agastric band and a perspective view of the gastric band in accordancewith another embodiment of the present invention.

FIGS. 15 and 16 respectively show a perspective view of a gastric bandand a cross sectional view of the gastric band in accordance with analternate embodiment of the present invention.

FIG. 17 is a cross sectional view of a gastric band in accordance withanother embodiment of the present invention.

FIGS. 18, 19, 20 and 21 respectively show a perspective view of a belt,a perspective view of a balloon, a cross sectional view of a gastricband and a perspective view of the gastric band in accordance with yetanother embodiment of the present invention.

FIGS. 22 to 31 show various embodiments of a balloon type gastric bandwith differing supply tube locations.

FIGS. 32 to 43 show various embodiments of suture tab extenders withdiffering attachment structures.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The detailed embodiments of the present invention are disclosed herein.It should be understood, however, that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, the details disclosed herein are not to be interpretedas limiting, but merely as the basis for the claims and for teaching oneskilled in the art how to make and/or use the invention.

With reference to FIGS. 1 and 2, a removable suture tab extender 100 foruse in conjunction with a gastric band 10 is disclosed. The extender 100is designed to enhance usage of gastric bands 10 and aid with the use ofthe gastric band latching mechanism 20. In particular, the extender 100provides a mechanism for assisting in the passage of the first latchingmember 22 of the latching mechanism 20 through the second latchingmember 26 of the latching mechanism 20 by either threading or pushingthe first latching member 22 through the second latching member 26 or byinserting a grasper through the second latching member 26, grasping thetip of the extender 112, and pulling it back through the second latchingmember 26 to lock.

To attach the extender 100 to the gastric band 10, the tether strap 108of the extender 100 is threaded through an aperture 38 in the tip of thelatching mechanism 20. This tether strap 108 is then glued to the restof the extender 100 inside a coupling indent 110. In accordance with analternate embodiment, and with reference to FIG. 10, the extender 300may be provided with a pocket 311 positioned at the end of the couplingindent 310 in which the tether strap 308 may be glued.

The extender 100 is easily removed or cut apart from the gastric band 10once the gastric band 10 is properly positioned and secured about thestomach, thereby minimizing the risk of “sharp” band edges if the banditself was cut. To remove the extender 100, the tether strap 108 is cutbetween the aperture 38 in the tip 36 of the gastric band 20 and thecoupling indent 110 containing the glued tether strap 108. This allowsthe extender 100 to be removed in one piece, leaving the gastric band100 completely intact without any “sharp” band edges.

The extender 100 may further be provided with a recess 109 (see FIG. 2)on the extender 100 for inserting scissors between the tip 36 of thegastric band 20 and the tether strap 108 to better facilitate cuttingoff the extender 100. The extender 100 is completely removed from thebody after it has been cut off of the gastric band 10. The extender 100also allows for the creation of an interim lock permitting adjustmentaround the stomach before final locking of the latching mechanism 20.Although a preferred embodiment has the extender cut off for one pieceremoval from the gastric band body, an alternate embodiment would entailleaving the extender in place on the gastric band and utilizing theinterim lock (that is, the retention member 114, 214 that is describedbelow in greater detail) as an additional permanent locking position foruse with varying stomach sizes.

In practice, and with reference to FIG. 3, the present suture tabextender 100 is secured to the first end 14 of the gastric band 10adjacent the first latching member 22 to form a single band/extenderfunctional unit. Thereafter, the gastric band 10, with the extender 100secured thereto, is inserted behind the stomach. The first latchingmember 22 of the latching mechanism 20, as well as the extender 100, arethen pushed or pulled through the second latching member 26 of thelatching mechanism 20. The addition of the present suture tab extender100 provides a longer region for grasping and manipulation of the firstlatching member 22 as it is passed about the stomach and through thesecond latching member 26.

In accordance with a preferred embodiment, and as will be discussedbelow in greater detail, the suture tab extender 100 is an elongated,elastomeric component that attaches to the first end 14 of the gastricband 10 to assist in mating and locking the first latching member 22with the second latching member 26. The extender 100 is preferablyattached to a tab 24 at the first end 14 of the gastric band 10 to holdthe extender 100 in place. The extender 100 is removable with one cutthrough the tether strap 108 on the extender 100 and incorporates arecess or an open recess, for example, a cuplike feature, 106 forcoupling the first end 14 of gastric band 10 and extender 100 closetogether so as to move as an integral unit.

More specifically, and as will be greater appreciated based upon thefollowing disclosure, the tab 24 of the gastric band 10 is positionedwithin the recess 106 of the extender 100 and is safely and securelycoupled thereto using a tether strap 108. In addition, and in accordancewith the preferred embodiment, the second end of the extender mayinclude a suture loop 105 for compatibility with a Goldfinger-likedevice 150. As those skilled in the art will certainly appreciate, theGoldfinger-like device 150 assists in passing the gastric band 20through the retro-gastric tunnel. Alternately, for surgeons who useother devices for passing the gastric band 20 through the retro-gastrictunnel, the gripping section, or flat tip, 112 of the extender 100 iscompatible with these band-passing devices as well. In general aGoldfinger instrument is an articulating band passing device used toperform blunt dissection behind the stomach before passing the gastricband. It is articulated and fed behind the stomach. In the tip of theGoldfinger instrument there is a notch that a suture loop can catch on.Once the suture is caught, the Goldfinger instrument is pulled out ofthe retro-gastric tunnel and the suture loop pulls the band with it.Alternately, to facilitate use with these other band passing-devices, alength of the extender may be round like tubing) behind the flat tip sothat the extender is easier to orient.

The removable extender 100 is designed for use with a variety of gastricbands. By way of example, the extender is designed for use with gastricbands as disclosed in commonly owned U.S. patent application Ser. No.11/182,072, filed Jul. 15, 2005, entitled “LATCHING DEVICE FOR GASTRICBAND”, which is incorporated herein by reference.

In general, and with reference to FIGS. 4, 5 and 5 a, the gastric band10 includes a band body 12 having a first end 14 and a second oppositeend 16. The band body 12 and latching mechanism 20 are preferablymanufactured from silicone. Although, and as will be discussed below ingreater detail, the gastric band is a balloon type gastric band, thepresent latching mechanism may be used in conjunction with a variety ofband structures without departing from the spirit of the presentinvention.

As briefly mentioned above, the gastric band 10 is shaped anddimensioned to circumscribe the stomach at a predetermined locationreducing the size of the stomach. The gastric band 10 employs a flexiblelatching mechanism 20 capable of locking and unlocking withoutdestruction of the latching mechanism 20 or significant reduction inretention capabilities after re-locking. The first and second ends 14,16 respectively act as both male and female members depending on thedirection of motion and intent to lock or unlock the latching mechanism20 of the present gastric band 10.

The first end 14 includes a shell member, or first latching member, 22generally composed of a hollow, half-moon shaped shell with a tab 24 forgripping and pulling through a collar member, or second latching member,26 composed of a semi-circular shaped aperture 30 on the second end 16.The half-moon shell of the first latching member 22 collapses as it ispulled or pushed through the collar member 26 by a grasper. The collarmember 26 includes a tongue 28 such that the shell member 22 slidesthrough the semi-circular shaped aperture 30 and under the tongue 28during latching. Once the shell member 22 passes the tongue 28, theroles change. The first end 14 functions as a female component when theshell member 22 resiliently returns to its original shape and is allowedto slide back onto the second end 16 (now a male component) and over thetongue 28. As such, the shell member 22 functions as both a malecomponent and female component during operation of the latchingmechanism 20 and the collar member 26 functions as both a male componentand female component during operation of the latching mechanism 20; thatis, the shell member 22 functions as a male component during insertionthrough the collar member 26 and a female component thereafter when thetongue 28 is seated therein. Unlocking is achieved by employing graspersto pull the first end 14 forward away from the second end 16 removingthe tongue from the shell member 22. The M-shape of the shell member 22permits it to collapse and move under the tongue 28 and through thecollar member 26.

More particularly, the shell member 22 at the first end 14 of thegastric band 10 is generally a half-moon shaped shell with an open, wideend 32 tapering toward a narrow end 34 adjacent the tip 36 of the firstend 14. The shell member 22 is substantially hollow and is formed from amaterial, for example, silicone, which permits compression and expansionthereof.

Referring to FIG. 5 a, the shell member 22 is formed with asubstantially M-shaped outer surface 23 a when viewed from the wide end32 thereof. That is, the outer surface of the shell member 22 has asubstantially M-shaped profile, while the inner surface 23 b of theshell member 22 adjacent the wide end 32 has a substantially smoothsemi-circular profile. The single M-shaped profile has been found toimprove flexibility and control as the shell member 22 is passed throughthe collar member 26. In addition, the inclusion of the M-shape in thewide end 32 of the shell member 22 permits ease of unlocking as it willbe easier and more controllable for one to compress the shell member 22.

The shell member 22 is slid through the collar member 26 as discussedabove. Thereafter, the center 54 of the M-shaped wide end 32 returns toits original shape and fits over the tongue 28. When the gastric band 10is unlatched, the shell member 22 is pulled forward away from the collarmember 26 and the M-shaped shell member 22 permits it to move under thetongue 28 and through the collar member 26. The preformed shape of theshell member 22 not only acts as a guiding feature for the tongue 28 toslide over the shell member 22 during unlocking, but will also allow theshell member 22 to more easily slide back through the aperture 30 of thecollar member 26.

An aperture 38 is formed within the tab 24 adjacent the tip 36 of thefirst end 14 and the narrow end 34 of the shell member 22. The aperture38 is shaped and dimensioned for receipt of a suture or grasper commonlyused in the installation of gastric bands. In addition, the tab 24 isformed with protrusions 39 assisting in grabbing the tab 24 duringlocking and unlocking.

Also at the first end 14, but on the opposite side of the shell member22 from the aperture 38 and adjacent the wide end 32 of the shell member22 is a rearwardly extending gripping member 51. The gripping member 51is shaped and dimensioned to permit dual directional access for lockingand unlocking of the latching mechanism 20. More particularly, thegripping member 51 includes protrusions 56 along the top and bottomsurfaces 53, 55 thereof. These protrusions facilitate gripping thereofalong a first directional orientation. The gripping member 51 is furtherformed with an “hour glass” shape having a reinforced central section57. The reinforced central section 57 allows for gripping in a seconddirectional orientation.

Secure fastening of the shell member 22 with the collar member 26 isachieved by ensuring that after the shell member 22 compresses whilepassing through the collar member 26, the shell member 22 returns to itsoriginal shape and the wide end 32 of the shell member 22 abuts with thefirst edge 46 of the collar member 26.

Latching is further enhanced by providing the collar member 26 with atongue 28 extending from the collar member 26 away from the tip 50 ofthe second end 16. The tongue 28 is shaped and dimensioned to seatwithin the wide end 32 of the shell member 22 after the shell member 22has passed through the collar member 26 and the gastric band 10 istensioned as the first and second ends 14, 16 are drawn toward eachother with the shell member 22 straining to move back through the collarmember 26 toward an unlatched positioned. With this in mind, the tongue28 may be downwardly oriented such that it slides with the shell member22 in a convenient and reliable manner. The tongue 28 may be distinctlycolored to provided an indication as to whether the latching mechanism20 is properly locked.

Gripping of the second end 16 is further enhanced through the provisionof a forward facing gripping member 58, that is, a gripping memberfacing the tip 50 of the second end 16. The forward facing grippingmember 58 is shaped and dimensioned to permit dual directional accessfor locking and unlocking of the latching mechanism 20. Moreparticularly, the gripping member 58 includes protrusions 59 along thetop and bottom surfaces 62, 64 thereof. These protrusions 59 facilitategripping thereof along a first directional orientation. The grippingmember 58 is further formed with an “hour glass” shape having areinforced central section 60. The reinforced central section 60 allowsfor gripping in a second directional orientation.

The gripping member 58 is shaped and dimensioned to receive and centerthe shell member 22 as it passes through the collar member 26. Thegripping member 58 also assists in compressing the shell member 22 as itpasses through the collar member 26.

In accordance with a preferred embodiment of the present invention, thegastric band is a balloon-type gastric band as shown in FIGS. 11 to 16.With this in mind, the gastric band 410 is generally composed of areinforcing belt 412 to which an elongated balloon 414 is secured. Thebelt 412 includes a first end 416 and a second end 418 to which thefirst and second latching members 422, 426 are respectively secured. Thebelt 412 further includes an inner surface 428 and an outer surface 430.The outer surface 430 is substantially smooth and forms a substantialportion of the outer surface 431 of the gastric band 410 when it issecured about a patient's stomach. The inner surface 428 of the belt 412is shaped and dimensioned for attachment to the outer surface 438 of theballoon 414.

With regard to the balloon 414, it also includes a first end 432, asecond end 434, an inner surface 436 and an outer surface 438. The innersurface 436 is substantially smooth and is shaped and dimensioned forengaging the patient's stomach when the gastric band 410 is securedthereto. The outer surface 438 of the balloon 414 is shaped anddimensioned for coupling with the inner surface 428 of the belt 412.

Referring to FIGS. 11 to 16, the belt 412 and balloon 414 may berespectively coupled by either overmolding or separate molding withsubsequent adhesive bonding (similar numerals are used for the differentembodiments). Regardless of the manufacturing technique, the outersurface 438 of the balloon 414 is formed with a groove 439 shaped anddimensioned for receiving the belt 412. Referring to FIGS. 15 and 16,wherein the belt 412 is adhesively bound to the balloon 414, the groove439 is formed with a glue gap 439 a shaped and dimensioned for receiptof a small amount of adhesive without adversely affecting the positionof the belt 412 within the groove 439.

In accordance with an alternate embodiment, and with reference to FIG.17, it is contemplated the balloon 414′ and the belt 412′ may be coupledby adding a layer of uncured material 413′ (similar in composition tocomponents) between the balloon 414′ and belt 412′, and curing themtogether. In addition, a layer of reinforcing structure 415′ (mesh,dissimilar material, or higher durometer silicone material) is containedwithin the layer of uncured material 413′. This reinforcing structure415′ is encapsulated within the device upon assembly and curing, andprovide additional structure or different mechanical properties to theproduct.

In addition, and with reference to FIGS. 18 to 21, yet a further gastricband 410″ construction is contemplated in accordance with the presentinvention. In accordance with this embodiment, the belt 412″ is securedalong an internal surface 417″ of the balloon 414″, with the outersurface 428″ of the balloon 414″ forming the exposed outer surface 430″of the gastric band 410″. As with the embodiments disclosed above, theinternal surface 417″ is formed with a groove 439″ shaped anddimensioned for receiving the belt 412″. Secure positioning of the belt412″ within the groove 439″ is achieved through provision of a glue gap439 a″ along the groove 439″ and a retaining snap 439 b″ along thelength of the groove 439″. The glue gap 439 a″ is substantially similarto that employed in accordance with the embodiment disclosed withreference to FIGS. 16 and 17.

As to the retaining snap 439 b″, the groove 439″ is constructed withopposed, inwardly directed protrusions 439 c″ shaped and dimensioned toengage the belt 412″, and temporarily retain the belt 412″ within thegroove 439″, while the glue used to couple the belt 412″ and balloon414″ cures during the gluing operation. More particularly, the inwardlydirected protrusions 439 c″ are shaped and dimensioned to wrap about thebelt 412″ in a manner holding it within the groove 439 c″.

In accordance with a preferred embodiment, the belt 412″ is positionedwithin the balloon 414″ in the following manner. The belt 412″ isthreaded through one of the balloon openings 433″, 435″ on either end432″, 434″ of the balloon 414″. The retaining snap 439 b, specificallyprotrusions 439 c″, on the groove 439 of the balloon 414″ temporarilyhold the components together while they are being glued via a longneedle inserted between the balloon 414″ and the belt 412″. Alternately,it is contemplated the balloon can be overmolded onto the belt.

In accordance with preferred embodiments, and as briefly discussedabove, the balloon and belt may be secured together by either adhesivebonding, comolding, overmolding or mechanical connection (for example,coupling sleeves), which secures the balloon and belt in a mannerresulting in the coupling of these distinct gastric band components.Where the belt and balloon are overmolded, a plug 415 would be used toclose the core outlet in the balloon for the overmold and the plug 415would be integral to the gastric band structure (see FIGS. 14 &15). Asthose skilled in the art will certainly appreciate, co-molding isessentially the same procedure as overmolding, but materials ofdifferent properties are shot in the mold at the same time. As withovermolding, comolding requires a plug to close the core outlet in theballoon.

Regardless of how the product is molded or assembled together, the beltand balloon components may consist of the same materials or differentmaterials (material durometer, fillers such as BaSO₄, TiO₂, colorants,etc.). In addition, features within the same component (i.e. the lockingfeatures or end caps) may vary in composition. These features may beadhered to the rest of the product with adhesive, mechanical fastening(i.e., snap fits), welding, co-molding, or overmolding. Although thebelt is disclosed as being secured to an outer surface of the balloon,it is contemplated the belt may be internal or external to the balloonsurface or integrated into the balloon, without departing from thespirit of the present invention.

For assembly methods allowing the adherence of different components(that is, adhesive bonding, mechanical connection, overmolding), uniquebelt and balloon components may be combined to provide variableconfigurations. For example, belts with different locking mechanisms maybe interchanged with balloons of different lengths to provide thepossibility of multiple combinations of products.

The balloon 414 is constructed to enhance contact with the stomach wallwhen applied thereto. With this in mind, and as will be discussed belowin greater detail, the balloon 414 is constructed as a precurved, lowpressure, high volume balloon. The balloon 414 is constructed tomaintain a soft and flexible surface (low pressure) when applied to thestomach tissue. The balloon 414 is also constructed to provide 360degree coverage to prevent tissue pinching or discontinuities in stomachshape, and, as such, may employ the balloon construction disclosed incommonly owned U.S. patent application Ser. No. 11/182,070, entitled“GASTRIC BAND WITH MATING END PROFILES”, filed Jul. 15, 2005, which isincorporated herein by reference. The balloon 414 is further constructedsuch that it reaches it fully inflated and encircling configuration withminimal “folds”. In addition, the balloon 414 is constructed to exhibitno folds or creases (single axis, not dual axis) when all fluid isevacuated therefrom.

With the foregoing in mind, the balloon 414 employed in accordance witha preferred embodiment of the present application is constructed of anelastomeric material. Due to the design of this balloon, it does notinflate or expand in a manner causing high strain in balloon when filledduring gastric band adjustment. Rather, the balloon 414 is adapted toreceive a large volume of fluid under a relatively low pressure. In thisway, the balloon 414 receives fluid during application, but does notinflate or expand in a traditional manner creating strain along thewalls of the balloon 414. In other words, when the balloon 414 is filledup to the volume recommended to achieve maximum stomach restriction,there is no expansion of the balloon material. Instead, the balloon 414fills to some percentage of its total theoretical volume (that is,maximum fill volume). Since the balloon 414 is not filled even close toits maximum fill volume, it remains low pressure, allowing the balloon414 to conform to the stomach rather than the stomach to a rigidballoon.

In accordance with a preferred embodiment of the present invention, theballoon 414 is designed with a maximum capacity of between approximately10 cc and approximately 18 cc, and preferably 18 cc, although it will befully filled for functioning in accordance with the present invention toachieve the smallest stoma size with approximately 9 cc to approximately12 cc, and preferably 9 cc. By providing a balloon 414, which is not atits capacity when properly filled for functioning, the softness andconformance of the balloon is improved. While specific volumes aredisclosed in accordance with a preferred embodiment of the presentinvention, those skilled in the art will appreciate the filling volumesmay be varied without departing from the spirit of the presentinvention.

In addition, the balloon 414 is fabricated such that it exhibits acurved configuration when unstressed. Although a variety of curvaturesare possible within the spirit of the present invention, the curvedconfiguration is designed to offer a radius of curvature ofapproximately 0.5 inches to approximately 1.5 inches. In addition, it iscontemplated the balloon may have a varying radius as it extends aboutits length. In general, the balloon curvature is designed to approximatethe curvature required to bring the first and second latching members422, 426 into approximation or contact when the balloon 414 is unbiasedand left to assume a relaxed configuration. By fabricating the balloon414 with an inherent curvature, folds created upon the application offluid are substantially decreased. With this in mind, the belt issimilarly pre-curved to reduce folds and approximate the first andsecond latching members 422, 426.

As those skilled in the art will certainly appreciate, the belt 412 isconstructed to have a curvature approximately the same that of theballoon 414 such that undesirable tension between the belt 412 andballoon 414 is reduced. In addition, and in consideration of theprecurved nature of the belt 412, the belt 412 readily conforms to theouter surface of the stomach and the belt 412.

Contact with the stomach tissue is further enhanced by providing theballoon 414 with a concave cross-section along the balloons innersurface 436. This cross sectional configuration helps to facilitateevacuation and straightening thereof.

By implementing the structural criteria outlined above, the balloon 414deflates with no creases or bulges forming on the inner surface 436 ofthe balloon 414, a low pressure and pre-curved balloon 414 is achievedand the balloon 414 changes shape when it is filling (zip-lock bagfilling up). As to the change in shape, the balloon 414 is constructedsuch that it has a relatively wider and flatter cross section prior tofilling along a cross section transverse to the longitudinal axis of theballoon 414. When the balloon 414 is subsequently filled duringapplication to the stomach of a patient, the transverse cross sectionalshape of the balloon 414 changes to that of a rounder balloon exhibitinga narrower cross section with a greater distance between the inner andouter surfaces 436, 430 thereof. With this in mind, it is furthercontemplated that the balloon cross section may be molded in a roundedrectangular shape, wherein the “corners” provide support, distribute thechange in shape and reduce folds. By providing a balloon which is wideand flat prior to filling, the distance between the inner surface of theballoon and the belt is reduced. This reduces the ultimate profile ofthe gastric band and improves the ability of the gastric band to bereadily delivered for deployment.

As those skilled in the art will certainly appreciate, a supply tube isused to connect the internal cavity of the balloon of the gastric bandwith a pressurized fluid source. The utilization of the tube with aremote fluid source allows for controlled inflation and deflation of theballoon in a predetermined manner. The exact position of the tube isimportant in that the surgeon does not want tubing to be a visualobstruction during locking and/or other manipulation of the gastricband. In addition, once placement of the gastric band is complete, thetube should not cause irritation to surrounding tissue (for example,sticking directly into the liver or spleen). Surgeons also do not wantto pull the tube through a retro-gastric tunnel, since they cannoteasily see if the tissue is being damaged. The tube should also be ableto act as a safe grasping location for manipulation of the gastric band,the tube must not kink at the junction to the gastric band and preventfluid flow, and the tube location should facilitate passage of the bandthrough a small trocar.

With this in mind, and in accordance with various preferred embodimentsof the present invention, different tube placements are shown withreference to FIGS. 22 to 31. As each these various embodiments show, thetube is positioned at an end of the gastric band. By positioning thetube at an end of the gastric band it has been found that forces uponthe tube, gastric band, and, ultimately the stomach, are reduced. Thispositioning also enhances the ability of the tube and gastric band toflex for insertion and expand to its original shape upon deployment.

Referring to FIG. 22, the tube 540 is oriented to exit the gastric band510 from the outer surface thereof. In accordance with a preferredembodiment of this design, the tube 540 is positioned such that is comesout the outer surface 531 of the gastric band 510 just below alongitudinally extending midline 542 of the gastric band 510. The tube540 is positioned so that is placed clear of the latching mechanism 520and obliquely angled relative to the longitudinal axis (in accordancewith a preferred embodiment at an angle of approximately 34°of thegastric band 510 to allow easy insertion through a trocar.

Referring to FIG. 23, the tube 640 is molded on the second end 634 ofthe balloon 614. In particular, the tube 640 is molded at the very endof the balloon 614, and is integrated into the balloon shape. As withthe prior embodiment, the tube 640 is obliquely oriented relative to thelongitudinally axis of the gastric band 610 and is similarly positionedbelow a longitudinally extending midline of the gastric band 610. Theoffset allows for the balloon ends 632, 634 to meet without interferencefrom the tube 640.

A further embodiment is shown with reference to FIG. 24, wherein thetube 740 exits the balloon 714 off a lateral side 744, that is, a verybottom surface, of the balloon 714 as it is positioned within thepatient. The tube 740 entry point is substantially aligned with thesecond latching member 726 relative to the longitudinal axis of thegastric band 710. As with the prior embodiments, the tube 740 isobliquely oriented relative to the longitudinally axis of the gastricband 710.

As shown in FIGS. 25 and 26, the tube 840 connection is integrated intoone of the sides of the latching members. In accordance with thedisclosed embodiment, it is integrated into the second latching member826, although it is contemplated it could be integrated with the firstlatching member 822 without departing from the spirit of the presentinvention. The tube 840 enters the second latching member 826 andextends therethrough into the body of the balloon 814. Once the tube 840is inside the body of the balloon 814, it angles to the centerline (ormidline 842) of the balloon 814 for even filling of saline. The tube 840is also obliquely oriented relative to the longitudinally axis of thegastric band 810 and is similarly positioned below a longitudinallyextending midline 842 of the gastric band 810. The offset allows for theballoon ends 832, 834 to meet without interference from the tube 840.

Yet other embodiments are shown respectively with reference to FIGS. 27and 28. In accordance with one embodiment as shown in FIG. 27, the tube940 is molded into the plug 946 used to cap the core portion of theballoon 914. In accordance with the other embodiment as shown in FIG.28, the tube 1040 is molded as an integral portion of the secondlatching member 1026. The fluid passageway, therefore, extends throughthe tube 1040, into passageways 1048 formed in the second latchingmember 1026 and ultimately into the balloon 1014. More particularly,once the tube 1040 enters into a bridge of the second latching member1026 (that is, where the second latching member 1026 defines theaperture), it splits into a bifurcated tube 1052 that goes into theballoon 1014 via both walls 1054 of the aperture 1030 of the secondlatching member 1026.

Still another embodiment is shown in FIGS. 29 and 30, wherein the tube1140 is integrated into one of the sides of the latching mechanism 1120,preferably, the second latching member 1126. The tube 1140 then runsthrough a gusset 1156 from the back of the second latching member 1126to allow for a low entry angle into the balloon 1114.

Referring to FIG. 31, the tube 1240 entry is integrated into the belt1212 (and more particularly, the second latching member 1226) to allowfor separate molding of the belt 1212 and balloon 1214. By beingattached to the second latching member 1226, the tube 1240 could be usedto find the location of the latching mechanism 1220 once the implant hasbeen encapsulated into the fibrous tissue. As with the priorembodiments, the tube 1240 is obliquely oriented relative to thelongitudinally axis of the gastric band 1210 and is similarly positionedbelow a longitudinally extending midline 1242 of the gastric band 1210.The offset allows for the balloon ends 1234 to meet without interferencefrom the tube 1240.

In addition, any of the tubing configurations disclosed with referenceto FIGS. 22 through 31 could incorporate some type of strain reliefmember to reduce fatigue as the tubing flexes back and forth in thebody. Such strain relief would be achieved by positioning a length ofthicker material at the tubing entry point into the balloon (see forexample 1156 on FIG. 29, similarly shown but not called out in FIG. 31).The length of thicker material allows the tubing to take a larger curveas it is bent away from the joint between the tube and the balloon. Inother words, this length of material that has been thickened increasesthe stiffness of the tubing in this region to allow the tubing to flexwithout kinking and moves the point of flexing further away from thevulnerable joint between the band, balloon, and tubing. The strainrelief member would be made preferably of silicone, but other materials(plastics, metals, etc.) could also be used. Also, in all of theseembodiments, the tubing to could be connected to either the belt or theballoon by any one of multiple manufacturing methods, such asovermolding or assembling and gluing.

Although the present invention is described for use in conjunction withgastric bands, those skilled in the art will appreciate the aboveinvention has equally applicability to other types of implantable bands.For example, bands are used for the treatment of fecal incontinence. Onesuch band is described in U.S. Pat. No. 6,461,292. Bands can also beused to treat urinary incontinence. One such band is described in U.S.Patent Application Publication No. 2003/0105385. Bands can also be usedto treat heartburn and/or acid reflux. One such band is described inU.S. Pat. No. 6,470,892. Bands can also be used to treat impotence. Onesuch band is described in U.S. Patent Application Publication No.2003/0114729.

Referring to FIGS. 1 and 2, the extender 100 includes an elongated bodymember having a first end 102 and second end 104. The first end 102includes an open recess 106 shaped and dimensioned to receive the tab 24of the first latching member 22 at the first end 14 of the gastric band10. The first end 102 of the extender 100 is further provided with atether strap 108. The tether strap 108 is shaped and dimensioned forpassage through the aperture 38 formed in the tab 24 and ultimateattachment within a coupling indent 110 formed in the outer surface ofthe first end 102 of the extender 100. In this way, the tether strap 108extending from the extender 100 loops through the tab 24 readilycoupling the first end 102 of the extender 100 the first latching member22 for selective attachment and detachment.

The second end 104 of the extender 100 includes a gripping section 112shaped and dimensioned to facilitate gripping thereof as the extender100 is passed through the collar member 26 and the gastric band 10 isapplied around a patient's stomach. In addition, there is a suture loop105 for compatibility with Goldfinger instruments 150 as discussed aboveand the gripping section, or flat end, 112 of the extender 100 iscompatible with other band passing devices. Between the first end 102and the second end 104 of the extender 100 is formed a laterallyextending retention member 114. The retention member 114 issemi-circular when viewed along a planar, transverse cross section. Theretention member 114 tapers to widen as it extends toward the first end102 of the extender 100 in a manner creating a surface over which thecollar member 26 may slide during latching for interim attachment of theextender 100 to the collar member 26. The taper creates an engagementsurface 118 which holds the collar member 26 between the enlarged firstend 102 of the extender 100 and the retention member 114 when the firstend 102 of the extender 100 is temporarily latched to the collar member26.

Although an extender with a recess and retention member in accordancewith a preferred embodiment is disclosed above, the extender may takeother forms without departing from the spirit of the present invention.For example, and in accordance with another preferred embodiment shownwith reference to FIG. 9, the extension member 200 includes an elongatedbody member having a first end 202 and second end 204. The first end 202includes an enclosed, pocket recess, more particularly a pocket, 206shaped and dimensioned to fully receive the tab 24 of the first latchingmember 22 at the first end 14 of the gastric band 10. The first end 202of the extension member 200 is further provided with a tether strap 208.The tether strap 208 is shaped and dimensioned for passage through theaperture 38 formed in the tab 24 and ultimate attachment within acoupling indent 210 formed in the outer surface of the first end 202 ofthe extension member 200. In this way, the first end 202 of theextension member 200 may be readily and selectively secured and detachedfrom the first latching member 22.

The second end 204 of the extension member 200 includes a series ofprotrusions 212 shaped and dimensioned to facilitate gripping thereof asthe extension member 200 is passed through the collar member 26 and thegastric band 10 is applied around a patient's stomach. The second end204 also includes a suture loop 205 extending therefrom. Between thefirst end 202 and the second end 204 of the extension member 200 isformed a laterally extending retention member 214. The retention member214 includes first and second engagement members 216, 218. Theengagement members 216, 218 are tapered to widen as they extend towardthe first end 202 of the extension member 200 in a manner creating asurface over which the collar member 26 may slide during latching forinterim attachment of the extension member 200 to the collar member 26prior to complete latching of the gastric band 10 latching mechanism 20(after which the extension member 200 is detached from the gastric band10). The taper creates opposed engagement surfaces 220, 222 which holdthe collar member 26 between the enlarged first end 202 of the extensionmember 200 and the engagement members 216, 218 when the first end 202 ofthe extension member 200 is temporarily latched to the collar member 26.

Regardless of the extender construction utilized in accordance with agastric band, it is important the extender be readily accessed forremoval with little possibility for error. The two key issues in removalof an extender revolve around a surgeon's ability to identify theextender, in particular, that part of the extender requiringmanipulation for removal thereof, and proceed to remove the extending inaccordance with the removal mechanism employed. With this in mind,various embodiments for ensuring clear visualization and convenientcutting have been developed. Any of the embodiments described below canincorporate a visual indicator such as color (on either the entireextender, the tether strap, or the only the region to be cut) or avisible suture to indicate to the surgeons that this is a separatecomponent from the gastric band that should be removed. In addition,these embodiments also provide various means in which the extender maybe attached to the gastric band (tether strap, suture, etc.).

More particularly, and with reference to FIGS. 32, 33, 35 and 36, theextender 1300 adjacent the first end 1302 thereof or the tether strap1508, 1608 of the extender 1500, 1600 is provided with one or more bumpsor ramps 1330, 1530, 1630 at a location adjacent the open couplingindent, or pocket, 1310 into which the tether strap 1308, 1508, 1608 ofthe extender 1300, 1500, 1600 is to be positioned. By providing a bumpor ramp 1330, 1530, 1630 at this position (on either the first end ofthe extender or on the tether strap), the tether strap 1308, 1508, 1608is held above the first end 1302 and the surgeon is able to readilyvisualize the location of the tether strap 1308, 1508, 1608. The bump orramp 1330, 1530, 1630 location is at a position adjacent the point atwhich the tether strap 1308, 1508, 1608 is to be cut for removal of theextender 1300, 1500, 1600 and, therefore, provides the surgeon a visualindicator as to the cut location. In accordance the embodiment shownwith reference to FIG. 35, two bumps 1530 a, 1530 b wrap completelyaround the tether strap 1508 and define an area at which a surgeonshould cut the tether strap 1508.

In addition to improving visualization of the tether strap, in eachembodiment the bumps or ramp raise the tether slightly above the gastricband, increasing the space between the tether and the gastric band toprovide an improved passageway for position scissors therein for cuttingof the tether and ultimate removal of the extender. Visualization of thecutting location in accordance with this embodiment is enhanced byproviding a gap or a notch 1332, 1432, 1532 along the tether strap 1308,1408, 1508 (see FIGS. 32, 33, 34 and 35). In particular and withreference to FIGS. 32, 33 and 43, the suture loop at the second end ofthe extender 1300, 2200 is continued throughout the body of the extender1300, 2200 with the suture 1334, 2234 extending through the tether strap1308, 2208 and functioning as a reinforcing member. However, a portionof the suture 1334, 2234 is exposed along the tether strap 1308, 2208 ata predetermined location such that when the tether strap 1308, 2208 ispassed through aperture 38 of the gastric band tab 24 and wrapped aboutthe gastric band 10 to secure the two components together, the gap 1332,2232 is positioned at the desired location for cutting.

Similarly, and as is seen if FIGS. 34 and 35, the tether strap 1408,1508 may have a localized region that is smaller than the remainder ofthe tether strap 1408, 1508 allowing for cutting in a single step. Moreparticularly, the localized region is preferably a notch 1432, 1532formed along the tether strap 1408, 1508. In addition, because the gapor notch 1432, 1532 is readily differentiated based upon its physicalappearance from the remainder of the tether 1408, 1508, a surgeon mayeasily identify the location requiring cutting. It is contemplatedeither the notch or gap design could be used in conjunction with thebump described above with reference to FIGS. 32, 33, 36, 42 and 43,although these designs could certainly be employed without the bumpwhere certain design considerations dictate.

Other embodiments are disclosed with reference to FIGS. 37, 39 and 40.These embodiments employ a reinforcing member, for example, a suture1734, 1934 to aid in the connection of the extender 1700, 1900 to thetip of the gastric band. In one application (see FIG. 37), the suture1734 holds the tether strap 1708 down upon the body thereof. As such,and rather than cutting the tether strap 1708 itself as disclosed abovewith reference to the various embodiments, the securing suture 1734 iscut to thereby release the tether strap 1708 for removal of the extender1700. Alternately, the suture may be used to tie down the strap and assuch, secure the tether to the extender without the assistance ofadhesive. Although a suture is disclosed as a reinforcing member inaccordance with a preferred embodiment, other reinforcing structures,for example, mesh, may be used within the spirit of the presentinvention.

In another related embodiment shown in FIGS. 39 and 40, the suturematerial of the suture loop 1905 is extended to run the length of theextender 1900 such that the suture material 1934, extends from the firstend 1902 of the extender 1900 (substantially replacing the tether of theprior embodiments). This allows the extender 1900 to wrap a suture 1934through an aperture 38 in the tip of the gastric band 10 and engage aprojection 1936 extending from the first end 1902 of the extender 1900.In addition to securing the gastric band in a reliable and convenientmanner, this embodiment provides additional benefits in that the suture1934 now has a loop at the first end 1902 and the second end 1904 of theextender 1900. This increases the strength of the extender 1900 becausethe suture cannot pull out of the extender independent of extendermaterial failure.

Referring to FIG. 38, another embodiment is disclosed. In accordancewith this embodiment, the tip 1812 of the gastric band 1810 is seatedwithin the recess 1806 formed in the extender 1800. However, the recess1806 and the tip 1812 of the gastric band 1810 include a snap featureproviding a semi-mechanical locking mechanism between the gastric band1810 and the extender 1800. Such an embodiment would improve the abilityof the extender 1800 to lead and guide the tip 1812 of the gastric band1810 in concert without twisting or flipping. Such a semi-mechanicallocking mechanism could be utilized in conjunction with the other tethersecuring arrangements as a means for providing redundant securing of theextender to the gastric band. It is further contemplated this embodimentmay have suture 1811 around the tip 1812 of the gastric band 1810 andthe recess 1806 of the extender 1800 (like FIG. 37) to compress theregion where the snap fitting tip 1812 fits within the recess 1806 ofthe extender 1800. When the surgeon cuts and removes the surroundingsuture 1811, they can then expand the flexible silicone extender 1800over the snap fitting tip 1812 on the front of the tab to separate theextender 1800 from the gastric band 1810 in one piece.

Further and with reference to FIG. 41, a suture 2034 is similarlyutilized in securing the extender 2000 to the gastric band. However, theprojection 2036 to which the extender 2000 is secured is designed suchthat it may be peeled away. As such, when it is desired to remove theextender 2000, one need only peel away the projection 2036 to releasethe extender 2000 and thereby no cutting is required.

Referring to FIG. 42, another embodiment is disclosed. In accordancewith this embodiment, the tether 2108 of the extender 2100 is lengthenedto allow the glue position 2138 to be moved a forward position on theopen recess 2106 extender 2100. This allows the tether 2108 of theextender 2100 to be cut at line 2140 to remove the extender 2100. Moreparticularly, the open recess 2106 includes a forward and 2106 apositioned toward the middle of the extender 2100 and a rearwardposition 2106 b positioned near the first end 2102 of the extender 2100.The glue position 2138 is at the forward end 2106 a. This is still aone-piece removal, only the length of the location for cutting haschanged. This embodiment allows the tether 2108 to bow for improvedaccess with scissors or other tools when the front of the extender isflexed upwardly since the tether is only glued at one end 2106 a.

In accordance with yet another embodiment, and with reference to FIG.43, a flange or stopper 2242 is positioned at a preset point along thelength of the tether 2208. This enables positioning of the gap 2232 inthe tether 2208 relative to the position of the extender 2200 where thesuture 2234 needs to be cut and to avoid having suturing contact withthe gastric band hole during band pulling. The stopper 2242 ispositioned to engage the tab surrounding the aperture so as to limit theextent to which the tether 2208 may pass therethrough. The portion ofthe tether 2208 adjacent the stopper 2242 may be tapered and the sectionthat is positioned inside the aperture of the gastric band can be largerin cross section to provide a snug fit with the hole of the gastricband. As with prior embodiments the tether will includes a gap ornotched section for identification and cutting thereof. In addition, thesuture loop runs fully through the extender and may be utilized by tyingit into a knot that is molded within the enlarged section of the stopperso as to improve the strength of the extender tether.

While the preferred embodiments have been shown and described, it willbe understood that there is no intent to limit the invention by suchdisclosure, but rather, is intended to cover all modifications andalternate constructions falling within the spirit and scope of theinvention.

1. A gastric band, comprising: a balloon shaped and dimensioned tocircumscribe the stomach at a predetermined location; the balloonincludes a longitudinally extending body; a supply tube secured to theballoon for fluid communication with an internal cavity of the balloon,wherein the balloon includes a longitudinally extending midline and thesupply tube is oriented at an oblique angle relative to thelongitudinally extending midline.
 2. The gastric band according to claim1, wherein the supply tube is coupled to the balloon at a position belowthe longitudinally extending midline.
 3. The gastric band according toclaim 1, wherein the supply tube is oriented at approximately 34°relative to longitudinally extending midline.
 4. The gastric bandaccording to claim 1, wherein the supply tube is positioned at an end ofthe balloon.
 5. A gastric band, comprising: a balloon shaped anddimensioned to circumscribe the stomach at a predetermined location; theballoon includes a longitudinally extending body; a supply tube securedto the balloon for fluid communication with an internal cavity of theballoon, wherein the balloon includes a lateral side and the supply tubeis coupled to the balloon along the lateral side.
 6. The gastric bandaccording to claim 5, wherein the supply tube is oriented at an obliqueangle relative to the longitudinally extending midline.
 7. The gastricband according to claim 5, wherein the supply tube is aligned with alatching member along the length of the gastric band.
 8. A gastric band,comprising: a balloon shaped and dimensioned to circumscribe the stomachat a predetermined location; the balloon includes a longitudinallyextending body; a supply tube secured to the balloon for fluidcommunication with an internal cavity of the balloon, wherein the supplytube is integrated with a female latching member of the gastric band. 9.The gastric band according to claim 8, wherein the supply tube isobliquely oriented relative to a longitudinally axis of the gastricband.
 10. The gastric band according to claim 8, wherein the supply tubeis positioned below a longitudinally extending midline of the gastricband.
 11. The gastric band according to claim 1, wherein the supply tubeis integrated into a belt of the gastric band.